FDA.reportPublic FDA data

Hand Sanitizer

Manufacturer
Valley of the Sun Cosmetics LLC
Effective date
2020-11-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:50

Label at a glance#

ProductHand Sanitizer
Active ingredientALCOHOL
Label structure12 sections

Indications and uses

Hand Sanitizer is to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30ºC (59-86°F) Avoid freezing and excessive heat above 40ºC (104°F)

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 80% v/v

Purpose

OTC - PURPOSE SECTION

Antimicrobial

Uses

INDICATIONS & USAGE SECTION

Hand Sanitizer is to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame.

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

Stop use and ask doctor if irritation or rash occurs. These may be signs of a serious condition.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30ºC (59-86°F)
  • Avoid freezing and excessive heat above 40ºC (104°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (aqua), glycerin, carbomer, acrylates/C10 30 alkyl acrylate crosspolymer, aminomethyl propanol, hydrogen peroxide, retinyl palmitate (vitamin A), tocopheryl acetate (vitamin E), cannabis sativa (hemp) seed oil

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hand Sanitizer 80% Alcohol (no fragrance), 8oz/236ml, NDC: 76523-080-08

LabelLabelProduct picture FrontProduct picture Front

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1041498ethanol 80 % Topical GelPSN1
1041498ethanol 0.8 ML/ML Topical GelSCD1
1041498ethanol 80 % Topical GelSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76523-080-082022-01-28C16284748780-1d6a99b39-9880-a426-e053-dadaa90af4c2Hand Sanitizer (no fragrance)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76523-080-08Hand Sanitizer236 mL in 1 BOTTLE, PLASTICGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76523-080HAND SANITIZER (ALCOHOL) GEL [VALLEY OF THE SUN COSMETICS LLC]1Legacy NDC, 1 package rows20201118_b44380ad-f7ac-6d80-e053-2995a90ae1d7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76523-08076523-080-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
HYDROGEN PEROXIDEBBX060AN9VIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
CARBOMER 934Z135WT9208IACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b44380ad-f7ad-6d80-e053-2995a90ae1d7b44380ad-f7ac-6d80-e053-2995a90ae1d72020-11-16WarningsExact identifier
spl id: b44380ad-f7ad-6d80-e053-2995a90ae1d7
spl set id: b44380ad-f7ac-6d80-e053-2995a90ae1d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.